25 Jun

At the health EPSCO Council of 22 June Hungary welcomed proposal for amending the regulation on supplementary protection certificates as it introduces a manufacturing waiver for export purposes. We do hope that the discussions will bear fruit in a short time in order to achieve its benefits as soon as possible.

On the other hand, In our view, and taking into account the Commission’s impact assessment, the competitiveness and public health benefits remain might remain limited, because

-             the draft Regulation does not provide for a manufacturing waiver for stockpiling purposes as well, which would allow for actual “day-1 entry”,

-             the transitional measure restricts the application of the waiver to certificates granted on or after the expiry of the third month after the publication of the amending regulation, which means that benefits related to the exception would be delayed by 10-15 years.

Hungary does not deny the importance of innovation, as it is also crucial for our health systems, on the other hand, we should not forget that timely generic entry contributes to the sustainability of national health systems, enhances patient access to new therapies and diversifies supply sources.

We expressed our hope that public health considerations would be duly taken into account during the discussions under the next Presidency and the amendments will be adopted very soon, contributing to a more balanced pharmaceutical market in the EU.

The importance of due attention to be paid to public health aspects was shared by Italy, Poland, the Netherlands, Romania, Greece, Portugal and Slovakia.

The Council held political debate on the draft regulation on health technology assessment. The Hungarian delegation made it clear, it continues to consider the Commission’s proposal as a negotiating basis and we express our hope that more flexibility could be identified which would increase the Member States' room for manoeuvre.

Ministers also held debate on the future of health in the EU. The delegation agreed on the continued cooperation on several fields where EU level cooperation can bring added value. Hungary particularly values cooperation in the field of health security and cross border public health threats, European Reference Networks, e-health, exchange of best practices in the field of prevention and health promotion and antimicrobial resistance.

Hungary also welcomes the Council conclusions on healthy Nutrition for children.